NCT05424003 Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
| NCT ID | NCT05424003 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Virginia |
| Condition | NAFLD |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-02-22 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.
Eligibility Criteria
Inclusion Criteria: * Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.) * Liver transplant surgery within 8-24 weeks prior to randomization * Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%) * Ability to provide informed consent * Discharged from the hospital following LT surgery * Tolerating diet * Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel) * Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate) * Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study Exclusion Criteria: * BMI≤ 27kg/m2 * GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2 * Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis) * History of gastroparesis * Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2 * History of pancreatitis * History of active malignancy post- LT with the exception of non-melanoma skin cancers * History of uncontrolled or unstable diabetic retinopathy or maculopathy * Acute cellular rejection * Hepatic artery thrombosis * Medical non-compliance * Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening * History of hypersensitivity to semaglutide or its excipients * Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures
Contact & Investigator
Mohammad S Siddiqui, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05424003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05424003 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05424003 currently recruiting?
Yes, NCT05424003 is actively recruiting participants. Contact the research team at sherry.boyett@vcuhealth.org for enrollment information.
Where is the NCT05424003 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT05424003 clinical trial?
NCT05424003 is sponsored by University of Virginia. The principal investigator is Mohammad S Siddiqui, MD at Virginia Commonwealth University. The trial plans to enroll 50 participants.